The present invention is directed to the delivery of inhalant medications to subjects having tracheotomies or tracheotomies, and is particularly directed to the delivery in subjects which have undergone laryngectomies.
A typical laryngectomy, and, particularly for a patient which has undergone a laryngectomy because of cancer which has arisen from long-term smoking, involves the removal of a significant portion of the larynx and the introduction of a surgical incision into the trachea via the neck to form a permanent opening in the skin and underlying structure that provides an air passage into the lung(s). In many instances, such a patient will use inhalant-based medications to treat emphysema and/or asthma or other lung deficiencies or airway impairments by directing aerosolized inhalant medications into the opening in the neck. The efficacy of such treatment can depend on the successful delivery of the proper medication dosage or ingredient to the desired region of the lung or airway.
Conventionally, inhalant-based medications such as aerosolized medications can be delivered in several ways. For example, some subjects directly insert a pressurized metered dose inhaler (xe2x80x9cpMDIxe2x80x9d) into or proximate the opening in the neck. However, unlike the oral use where the lips and mouth are able to substantially seal about the end of the pMDI device, the neck opening does not have the structure or control to correspondingly collapse about the device. In an attempt to overcome such a deficiency, others position an infant mask connected to an inhalant aerosolized drug chamber (such as an AeroChamber(copyright) connected to a pMDI) over the opening to deliver the medication into the opening. Unfortunately, the infant mask can be somewhat cumbersome and/or inconvenient to use. Furthermore, spraying medication from the pMDI directly into the opening can cause premature deposit of the medication and impede proper delivery as well as potentially injuring the delicate tissue of the trachea. The delivery shortcomings can, in turn, reduce the therapeutic treatment efficacy or value of the drug and potentially introduce undesirable and pathologic changes in the user""s airway.
It is therefore a first object of the present invention to provide a more effective and/or relatively convenient method of administering inhalable medications via the opening in the neck for laryngectomized subjects.
It is yet another object of the present invention to provide an improved manner of delivering aerosolized medications to a subject with a tracheotomy (i.e., a subject having a temporary opening formed in the neck) or a tracheostoma (i.e., a subject having a permanent or chronic opening formed in the neck).
It is an additional object of the present invention to provide less irritating, safer, periodic, inhalation-based drug deliveries through openings in the neck (which can be particularly useful for tracheotomy and/or tracheostoma subjects).
It is another object of the present invention to provide a device which can allow laryngectomy subjects to more effectively use off-the-shelf or conventional inhalers and/or inhalers with valved holding chambers or reservoirs.
These and other objects are satisfied by the present invention by an adapter which is in fluid communication with a conventional oral inhalation-based medication dispensing device and which is configured to penetrate the opening and direct the desired medications into a subject""s air passage such that it inhibits premature deposit of the medication. Preferably, the adapter alignably engages with the opening in the subject""s neck and substantially seals the flow path to more effectively deliver aerosolized medications therein. The adapter is particularly suitable to operate with an aerosolized drug delivery device such as an AeroChamber(copyright) and/or pMDI.
In a preferred embodiment, the adapter is attached to the AeroChamber(copyright) device and is configured with an arcuately shaped profile to direct the flow path (and thus the medication) through the opening and downwardly toward the lungs. The adapter can include a seating spacer (which can be a separate component or integrally formed onto the adapter body) to facilitate proper seating and to facilitate sufficient penetration of the end of the adapter to help reliably position the penetration end of the adapter in the user. The seating spacer can also stabilize the adapter about the user opening during operation. Penetration depth and/or the flow channel size and length of the adapter may be important for influencing air/medication flow direction as well as proper dispersion of the drug into the air passage (inhibiting premature deposit of the drug) and to the desired systemic or target region.
A first aspect of the invention is directed to an adapter for an inhalation based drug dispensing device having a medication dispensing exit flow port and a drug flow path associated therewith for use with a subject having a tracheotomy or a tracheostoma type opening in the neck. The adapter includes a tubular body having opposing first and second end portions and defining a flow path therebetween. The tubular body first end is configured to penetrate a (relatively short) depth into a subject through the opening in the neck such that it resides in the subject""s airflow path. The tubular body second end is located external to the user and is configured to engage with the inhalation-based drug dispensing device such that the tubular body flow path is in fluid communication with the drug dispensing device.
In a preferred embodiment, the drug-dispensing device comprises a pressurized metered dose inhaler assembled to a valved-reservoir or holding chamber. In this embodiment, the adapter is configured to engage with the mouthpiece of the valved holding chamber. However, the adapter can be used with the pMDI alone and thus, configured to with the mouthpiece of the pMDI. Preferably, the tubular body has an arcuate profile and in position and during use, the arcuate profile is configured to extend into and penetrate through the opening in the neck and direct the medication from the drug dispensing device generally downwardly into a user""s air flow path as it exits the tubular flow path. The adapter can also include a seating spacer as discussed above.
A second aspect of the present invention is an inhaler-based delivery system for administering aerosolized medications to a subject having undergone a laryngectomy and having an associated opening in the neck extending to an internal air flow passage. The system includes a pressurized metered dose inhaler having an aerosol chamber and exit port and an adapter having a tubular body with opposing first and second end portions and an internal flow path extending therebetween. The internal flow path is in fluid communication with the pressurized metered dose inhaler aerosol chamber. The adapter tubular body first end portion is sized and configured to enter into the opening of the laryngectomized user a sufficient distance to direct the inhalant based medication received from the pressurized metered dose inhaler through said adapter internal flow path and generally downwardly into the user""s air flow passage toward the user""s lower airway.
In a preferred embodiment, the system also includes a valved holding chamber or reservoir with an exit port positioned intermediate the pressurized metered dose inhaler and the adapter, all of which are in fluid communication with each other. The adapter tubular body second end portion is configured to sealably engage with the valved holding chamber or reservoir. Further, the adapter tubular body is preferably configured with an internal profile which has a gradual or reduced profile change and/or a smooth wall along its length (and particularly proximate the flow path at the junction of the adapter and mouthpiece) so as to reduce airflow turbulence attributed to same. As before, it is preferred that the system also include a seating spacer or seating spacer portion operably associated with a perimeter portion of the tubular body, positioned intermediate the first and second end portions such that it is spaced away from the first end portion. In position on the user, the seating spacer portion is configured and sized to reside against the skin of the user external to the opening to define (at least partially) the penetration depth of said first end portion into the opening. Preferably, the adapter tubular body second end portion is configured and sized to slidably engage with one of the pressurized metered dose inhaler or the valved-holding chamber.
An additional aspect of the present invention is a method of using an inhalation-based medication-dispensing device. The method includes the steps of providing an adapter having first and second end portions and an internal flow path therebetween to a laryngectomized subject having an opening in the neck; sliding the adapter second end portion onto the oral inhalation based dispensing device; inserting the adapter first end portion into the user air flow passage through the opening in the neck to a desired penetration depth; activating the inhalation based medication dispensing device to release the inhalant medication; and directing the inhalant medication into the adapter and then into the user air flow passage such that it is oriented generally downwardly toward the user""s pulmonary region or lower airway.
Still another aspect is a laryngectomy modification kit for oral inhaler systems, comprising a tubular adapter having opposing first and second end portions, the second end portion configured to slidably engage with a mouthpiece associated with the oral inhaler system. The kit also includes at least one seating spacer. The tubular adapter is configured to be inserted into the opening in the neck of a laryngectomized subject. The kit may include multiple size (and or shaped) seating spacers to allow a more customized fit for a user or multiple disposable seating spacers for easy change out by a user for each adapter.
The present invention allows laryngectomized subjects to more effectively use conventional and/or existing oral inhalers or inhalers with reservoirs or valved holding chambers by configuring the adapter to sealably engage with the mouthpiece of same and providing an easy to use (in a preferred embodiment it is configured such that it can be easily slid onto the conventional devices) extension which allows the adapter to enter the opening in the neck a sufficient operative depth. Indeed, the adapter penetration distance into the air passage is at a sufficient depth so as to facilitate operation of the inhaler even if the trachea collapses during delivery. By configuring easy to use adapters which can conveniently engage with off-the-shelf inhalers, laryngectomized subjects can more effectively employ inhalers directed to conventional oral (mouth) operation.
The foregoing and other objects and aspects of the present invention are explained in the specification set forth below.